Influence of Oral Treatment With Citicoline for the Prevention of Radiation Optic Neuropathy in Patients Treated for Uveal Melanomas With Proton Beam Therapy

Influence of Oral Treatment With Citicoline for the Prevention of Radiation Optic Neuropathy in Patients Treated for Uveal Melanomas With Proton Beam Therapy

Sponsors

Lead sponsor: Centre Hospitalier Universitaire de Nice

Collaborator: DENSMORE pharmaceuticals

Source Centre Hospitalier Universitaire de Nice
Brief Summary

Proton beam irradiation is the treatment of choice for uveal melanomas. It has favorable results in causing tumor regression while preserving the eye. Optic neuropathy has emerged consistently as an irreversible cause of visual loss in proton beam irradiated eyes. No neuroprotective strategies are available at present.

Citicoline is a choline agent precursor available as a dietary supplement. Citicoline conferred acute neuroprotection and enhanced neuroplasticity in experimental stroke models. In ophthalmology, citicoline has demonstrated a significant action in improving retinal and cortical responses in patients with optic nerve diseases (glaucoma, ischemic optic neuropathy). Citicoline also exhibits a very low toxicity profile in humans.

The purpose of the study is to demonstrate whether daily oral administration of citicoline in patients treated for uveal melanomas with proton beam therapy, prevents or delays the occurrence of radiation optic neuropathy. Changes in visual acuity, Pattern ERG and visual evoked potentials are measured. The tolerability/safety of the product is also evaluated.

Overall Status Active, not recruiting
Start Date June 25, 2012
Completion Date June 29, 2023
Primary Completion Date June 29, 2013
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Occurrence and delay of occurrence of radiation optic neuropathy Every 6 months
Secondary Outcome
Measure Time Frame
Visual function assessment Every 6 months
Enrollment 80
Condition
Intervention

Intervention type: Dietary Supplement

Intervention name: CITICOLINE

Description: Oral administration of CITICOLINE: Form: Powder for solution Dosage: 800mg per day duration: 5 years

Arm group label: CITICOLINE

Intervention type: Dietary Supplement

Intervention name: PLACEBO

Description: Oral administration of placebo: Form: Powder for solution duration: 5 years

Arm group label: Placebo

Eligibility

Criteria:

Inclusion Criteria:

- over 18 years old

- uveal melanoma with posterior marge located at less than 3 mm of optic papilla

- uveal melanoma treated with proton beam therapy with irradiation of optic head nerve

- visual acuity before proton beam therapy over 30 letters (with ETDRS test)

Exclusion Criteria:

- antecedent of acute glaucoma with angle enclosure

- antecedent of chronical glaucoma with angle aperture

- antecedent of optic neuropathy optique of congenital, ischemic, inflammatory or other origins

- antecedent of neovascular glaucoma

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Stéphanie BAILLIF-GOSTOLI, MD Principal Investigator Ophtalmology department, Nice University Hospital
Location
facility
CHU de NICE | Nice, 06000, France
Ophtalmology Departement, St Roch Hopital, Nice University Hospital | Nice, 06000, France
Location Countries

France

Verification Date

February 2018

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: CITICOLINE

Arm group type: Experimental

Description: Daily oral administration of 800 mg citicoline

Arm group label: Placebo

Arm group type: Placebo Comparator

Description: Daily oral administration of placebo

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov